Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01313377
First received: March 10, 2011
Last updated: June 30, 2016
Last verified: June 2016
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient's condition but not giving treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride together with oxaliplatin is more effective than observation in treating patients with biliary tract cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride together with oxaliplatin to see how well it works compared with observation in treating patients with biliary tract cancer that has been removed by surgery.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Drug: gemcitabine hydrochloride
Drug: oxaliplatin
Other: clinical observation
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Multicenter Randomized Study Comparing the Effect of Adjuvant Chemotherapy for Six Months With Gemcitabine-Oxaliplatin 85 mg/m2 (GEMOX 85) to Observation in Patients Who Underwent Surgery for Cancer of the Bile Ducts

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Toxicity of adjuvant chemotherapy [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 190
Study Start Date: July 2009
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM A: Gemox 85
Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)
Drug: gemcitabine hydrochloride Drug: oxaliplatin Procedure: adjuvant therapy Procedure: quality-of-life assessment
ARM B:
Observation until progression or death
Other: clinical observation Procedure: quality-of-life assessment

Detailed Description:

OBJECTIVES:

Primary

  • Compare disease-free survival (DFS) of patients with resected biliary tract cancer treated with adjuvant gemcitabine hydrochloride and oxaliplatin versus clinical observation.
  • Compare quality of life of these patients.

Secondary

  • Compare overall survival of these patients.
  • Determine the toxicity of the chemotherapy in these patients.
  • Explore prognostic factors for DFS including resection result (R0 vs R1), location of primary tumor (intrahepatic vs extrahepatic vs gallbladder), evolution of CA19-9, and lymph node involvement (N0 vs N+ and Nx). (Exploratory)
  • Study pathological factors in surgical specimens to identify main characteristics and phenotypic clinicoanatomical biliary tract cancers before therapy. (Exploratory)
  • Identify nontumor-associated liver injury and factors that may facilitate the emergence of biliary tract cancers. (Exploratory)
  • Identify signaling pathways that may predict response to therapy. (Exploratory)
  • Determine the molecular characteristics to differentiate tumors according to their position in the biliary tract (extrahepatic bile duct, intrahepatic cholangiocarcinoma site [hilar], and peripheral cholangiocarcinoma vesicle site). (Exploratory)

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 12 courses.
  • Arm II: Patients undergo clinical observation only every 4 weeks for 5 months. Quality of life is assessed at baseline, at 3 and 6 months, and then at all follow-up visits.

After completion of study therapy, patients are followed up at 6 months, every 3 months for 2 years, and then every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven adenocarcinoma of the intrahepatic bile ducts, gallbladder, or extrahepatic bile ducts

    • Mixed forms of hepatocholangiocarcinomas included provided the cholangiocarcinoma is predominant
  • Underwent surgical resection of the disease (R0 or R1) at least 4 weeks but no more than 13 weeks ago
  • Nonmetastatic disease as assessed by abdominal MRI and chest x-ray
  • No cancer of the pancreas or duodenum invading the bile duct and ampulla of Vater

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Hemoglobin ≥ 10 g/dL (transfusion allowed)
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Creatinine clearance > 40 mL/min
  • Prothrombin time > 60% OR INR < 1.5 (without anticoagulant therapy)
  • Transaminases ≤ 5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Conjugated bilirubin ≤ 35 μmol/L (after biliary drainage, if necessary)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No contraindications to oxaliplatin and gemcitabine hydrochloride therapy
  • Prior invasive cancer allowed provided it has been in complete remission for ≥ 5 years
  • No other concurrent invasive cancer except adequately treated carcinoma in situ of the cervix or basal cell carcinoma
  • No other severe, unresolved disease
  • No mental illness
  • No HIV positivity
  • No grade 1 angina or symptomatic angina ≥ grade 2
  • No sensitive peripheral neuropathy
  • No uncontrolled diabetes
  • No inability to undergo medical tests due to geographical, social, or psychological reasons
  • No prisoners or patients under guardianship
  • No Child B or C cirrhosis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior neoadjuvant chemotherapy or radiotherapy
  • No prior organ transplantation
  • No concurrent participation in another clinical trial of an experimental agent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313377

Locations
France
CHU - Hôpital Nord
Amiens, France, 80054
Centre Paul Papin
Angers, France, 49933
Institut Sainte Catherine
Avignon, France, 84082
Centre hospitalier de la Côte Basque
Bayonne, France, 64109
Hôpital Jean Minjoz
Besancon, France, 25030
Hôpital Avicenne
Bobigny, France, 93009
CHU Brest - Hôpital Morvan
Brest, France, 29200
CHU Côte de Nacre
Caen, France, 14000
CHU Estaing
Clermont Ferrand, France, 63003
Hôpital Beaujon
Clichy, France, 92118
Hôpital Henri Mondor
Créteil, France, 94000
Hôpital Bocage
Dijon, France, 21079
CHD Vendée
La Roche Sur Yon, France, 85925
Centre Léon Bérard
Lyon, France, 69008
Hôpital Privé Jean Mermoz
Lyon, France, 69373
Hôpital Edouard Herriot
Lyon, France, 69437
CHU Timone Adulte
Marseille, France, 13385
Hôpital Nord
Marseille, France, 13015
Institut Paoli Calmettes
Marseille, France, 13273
Hôpital Saint Joseph
Marseille, France, 13008
Centre Hospitalier Saint Eloi
Montpellier, France, 34295
Centre René Gauducheau
Nantes, France, 44805
Hôpital La Source
Orléans, France, 45067
Hôpital de la Pitié Salpétrière
Paris, France, 75651
Institut Mutualiste Montsouris
Paris, France, 75014
CHU Saint Louis
Paris, France, 75475
Hôpital Saint Antoine
Paris, France, 75012
Hôpital Européen Georges Pompidou
Paris, France, 75908
CHU de Poitiers
Poitiers, France, 86021
Centre Eugene Marquis
Rennes, France, 35042
CHU de Rouen - Hôpital Ch. Nicolle
Rouen, France, 76031
CHU Sainte-Etienne - Hopital Nord
Sainte-Etienne, France, 42255
Centre Paul Strauss
Strasbourg, France, 67065
Hôpital de Hautepierre / Hôpital Civil
Strasbourg, France, 67098
Hôpital Trousseau
Tours, France, 37044
CHU Brabois
Vandouevre Les Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Eveline Boucher, MD Centre Eugene Marquis
  More Information

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01313377     History of Changes
Other Study ID Numbers: CDR0000696193  FRE-FNCLCC-ACCORD-18/0803  FRE-FNCLCC-PRODIGE-12  EUDRACT-2008-004560-39  EU-20982 
Study First Received: March 10, 2011
Last Updated: June 30, 2016
Health Authority: France: Agence Française de sécurité Sanitaire des Produits de Santé

Keywords provided by UNICANCER:
adenocarcinoma of the extrahepatic bile duct
cholangiocarcinoma of the extrahepatic bile duct
liver and intrahepatic biliary tract cancer
localized extrahepatic bile duct cancer
adenocarcinoma of the gallbladder
cholangiocarcinoma of the gallbladder
localized gallbladder cancer

Additional relevant MeSH terms:
Liver Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016